Near-Infrared Imaging of Motor Imagery Effects in Spinal Cord Injury

Recruiting now · Not applicable

Conditions studied: SCI - Spinal Cord Injury, Motor Imagery, Brain-Computer Interfaces

In brief

The primary objective of this clinical trial is to investigate the efficacy of motor imagery-based brain-computer interface (MI-BCI) technology in improving motor function among patients with spinal cord injury (SCI), as well as its impact on cortical motor area function across varying states. To achieve this, the study will implement MI-BCI intervention in SCI patients, evaluate post-treatment motor function improvements, and assess changes in cortical motor area oxygen metabolism (via functional near-infrared spectroscopy, fNIRS) and neural activity (via electroencephalography, EEG). The ultimate goal is to establish a novel rehabilitation strategy for SCI. Specifically, the trial aims to: (1) determine whether MI-BCI effectively enhances motor function in SCI patients; and (2) clarify the differential effects of MI-BCI on cortical motor area function under distinct states (e.g., resting vs. task-performing) in this population. Participants will be randomly assigned to one of two groups: the experimental group will undergo MI-BCI training, while the control group will receive active cycling training (as a conventional rehabilitation control). Both interventions will be structured as 20-minute sessions, administered 5 days per week, over a total of 4 weeks.Pre- and post-treatment assessments will include: lower limb motor function (measured by the Lower Limb Motor Score), activities of daily living (evaluated via the Modified Barthel Index), walking capacity (quantified using the Spinal Cord Injury Walking Index), and cortical motor activity (captured through fNIRS and EEG measurements).

Key facts

Study ID: NCT07106060
Run by: Shengjing Hospital
People needed: 36
Starts: 2025-01-01
Expected to finish: 2026-02-01
Last updated by the study team: 2025-08-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

The vital signs are stable and the spine is stable, making the subject suitable for exercise testing.
Patients with spinal cord injury (SCI) who meet the international diagnostic criteria for SCI neurology revised by the American SCI Society in 2019 and have been diagnosed by CT or MRI.
The injury level of SCI is C5-T12, and the ASIA grade is A-C.
The course of the disease is ≤12 months (but the spinal shock period must have passed).
Age: 18-75 years old, regardless of gender.
Good cognitive function, able to understand and actively participate in the training program, and willing to sign the informed consent form for this clinical study.

You may not qualify if…

Those with tumors, tuberculosis, hematologic diseases, or dysfunction of important organs such as the heart and liver;
Those with unstable fractures;
Those with severe abnormal limb muscle tone and joint contracture deformities;
Those with severe pain that cannot tolerate activities;
Those with severe emotional problems who cannot cooperate to complete the study.

Where it is running

Rehabilitation Center of Shengjing Hospital, China Medical University — Shenyang, Liaoning, China (enrolling)

Full record on ClinicalTrials.gov

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